Modern mobile devices have converged most of the smartphone functionality into a thin, mobile, yet simple to use computing platform. Users want a simplified experience that eliminates multiple interfaces and also consolidates platforms to reduce costs. These consumer desires are pushing vendor solutions like laboratory information management systems (LIMS) and electronic laboratory notebooks (ELN) outside of their traditional boundaries. Convergence is changing the market landscape for vendors. The rush to offer a single ELN platform spanning multiple application needs is driving an unprecedented level of mergers and acquisitions (M&A). In the era of the iPad-savvy populous, a challenge for developers is to support the desires of convergence in a user experience that is inviting and pleasurable. The need for new capabilities should be supported in a modular, service-based architecture to avoid the mistakes of the unwieldy monolithic system. The future of ELN will require innovative and disruptive thinking to provide users with an engaging user experience far above traditional approaches.

Michael H. Elliott shares his views on how externalization workflow is impacting traditional data management architectures in the pharmaceutical industry. Pharmaceutical companies have adopted a more aggressive approach toward externalizing drug discovery. Some of them report a target of between 30 to 50 percent of discovery work to be through partner alliances. A full range of arrangements are being pursued, ranging from university collaborations for target identification, to medicinal chemistry with partners in China, to in vitro screening shops in India. A survey conducted by Atrium Research has revealed that only a few companies have a comprehensive externalization data management strategy, despite many of them being engaged in partnerships and collaborations. Eighty percent of these companies are exchanging biology data with partners via e-mail and Excel spreadsheets, despite having robust internal bioassay data management systems, electronic laboratory notebooks (ELN), and laboratory information management systems (LIMS).

Data management and workflow support through a modern ELN (electronic laboratory notebook) can help to alleviate the stress of biologics research and development (R&D). The capabilities an ELN must have are unlike those needed for chemistry or in vivo biology. Merck and Company was one of the companies that evolved the use of their ELN beyond their original paperless lab objective. Working with Merck, PE incorporated their BioAssay screening and RDLIMS sample tracktioning modules into their E-Notebook ELN and adapted them for structured biologics data capture, management and analysis. Any potential users to never underestimate the ELN's impact on culture and to make sure that management are fully behind the project. The functionality and the advantages is having a single database for housing all BTxPS non-GMP and GMP data to facilitate reporting of data across the development life cycle. Lonza is deploying IDBS' E-Workbook/BioBook ELN to over 300 users from bioprocess to analytical, supporting both non-GMP and GMP workflows on the same instance.

An area of accelerating market growth for electronic laboratory notebook (ELN) technology is in analytical sciences, specifically late state biopharmaceutical development and quality. The large number of ELN users in the un-regulated world of research has inspired organizations to gain similar improvements in efficiency downstream on the R&D continuum. Quality by design (QbD) initiatives combined with efforts to accelerate time-to-market, are motivating clients to evaluate solutions to expedite technology and method transfer. Progressing companies are turning to ELN as one of the tools to help build a bridge over the traditional development and quality gap. The work for developing a new method is freeflowing and lends itself well to many of the research ELN products on the market. A basic template in the ELN is used for documentation of objectives, materials, buffers, standards, instrument run conditions, and entry of a selective set of results like a representative chromatogram.

There are number of technologies that include electronic signatures, hash digests, and checksums, are used with ELN products to establish the authenticity of both users and records. Most all ELN records are electronically signed at some juncture for approvals and/or IP witnessing. Digital signatures are based on cryptography and adhere to the principle of non-repudiation, which means it cannot be denied that someone created or signed a record. The International Standards Organization (ISO) defines digital signatures as data appended to, or a cryptographic transformation of a data unit that allows a recipient of the data unit to prove the source and integrity of the data unit and protect against forgery. The US National Institute of Standards and Technology (NIST) suggests the SHA-2 algorithm, which uses 256-, 384- or 512-bit digests. The Public Key Infrastructure (PKI) X.509 standard uses digital signatures based on asymmetric encryption.

The seamless integration of electronic laboratory notebook (ELN) to other systems in the enterprise can eliminate the tedious efforts of manual data aggregation and manipulation. A study has found that any ELN suppliers position paperless as the key to lab productivity rather than a comprehensive focus on data flow and integration. ELN companies are adding LIMS-like task workflow, instrument calibration, reporting, and inventory. Three major scientific software providers are investing in bridging these technologies with ELN include Accelrys, CambridgeSoft, and IDBS. The goal of these three vendors include simplifying data flow between the ELN and other data sources, both internal and external. The access to data across sources allows new data relationships to be uncovered.

Electronic notebook technology (ELN) creates a searchable repository of experimental data and information and allows access to gain the operational benefits of knowledge sharing and collaboration. If a chemistry ELN containing all the structures of a potentially marketable new drug has lax security controls, then the impact to a business an be quite high if the data are stolen. Risk assessment should be continual and not a one-time event, as the nature of vulnerabilities and business value changes over time. Digital Loss Prevention (DLP) is one technology that can be used in conjunction with ELN to prevent copying data to removable media or sending data via e-mail. DLP will inspect content as it flows through the enterprise and track how it is being used, enabling a corporate-wide visibility into data utilization.

Integrating bioanalytical electronic laboratory notebook (ELN) into the workflow improves sample throughput and lowers costs of compliance. The IDBS BioBook deployment undertaken by Abbott Laboratories' BioAnalytical department specifically targeted laboratory throughput as the primary project justification. In this, SOP requirements are built into ELN templates that enforce capture of required information and perform any necessary calculations. The strategic eLab initiative at Johnson & Johnson's pharmaceutical company, deployed a large number of ELN seats across all biology R&D departments. Bayer Pharma AG and LabWare are working together to adapt both LabWare's LIMS and ELN products to address the needs of the bioanalytical laboratory. The automation of reports was the most important consideration of the project.

Formulations investment across the pharmaceutical sector is increasing to provide competitive advantages and improve bottom-line results. Electronic laboratory notebooks (ELN) allows organizations to improve the current state. ELN can act as a library of formulation designs and a repository for assay results generated by the partner laboratories. Some ELN vendors offer a relatively simple platform that can be used for basic formulations requirements, while others provide a feature-rich solution suitable from early development through commercialization. To create a common language, automate processes, and to expedite technology transfer from formulations through commercialization, several pharmaceutical companies are turning to the ANSI/ISA-88 and ANSI/ISA-95 standards (S88 and S95). Both have an extensive library of terminology definitions. Though the standards were designed originally for large-scale batch manufacture, many of the concepts and vocabularies can be applied to formulations and ELN.

Cloud computing and software-as-a-service (SaaS) are gaining popularity and find increasing use in several applications. A software supplier provides access to their software over the Internet for a monthly fee with data management services and support included in a cloud environment. Applications such as customer relationship management (CRM) and pharmaceutical clinical trials electronic data capture (EDC) have been successfully hosted by these external third parties for over a long period of time motivated by lower administration costs, absence of capital outlay, lack of available IT resources, and geographically dispersed user bases. Several electronic laboratory notebook (ELN) suppliers have introduced hosted solutions as an option to the traditional perpetual licenses installed at customer locations. A hosted private cloud is essentially a buzz term for a traditional hosting solution where a party maintains the application for an end-user client.